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The following message was posted to: PharmPK
What vehicle o formulation were used as routine vehicle in
toxicokinetics
studies by oral route in rats, dog o any experimental animal?. Some
people use
agar, carboxymethylcellulosa 1-2%. The regulatory agencies have any
recommendations?.
B.Santos
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The following message was posted to: PharmPK
there is no former recommendation for vehicle or formulation use in
preclinical toxicity studies. What you need to demonstrate is the
inocuity
of your vehicle by treating a group of animals with blank vehicles or
formulations. This would assess the vehicle safety and will help to
demonstrate the tox or non-tox of the active.
Regarding the vehicles used I am happy with suspensions in 0.5% aqueous
solutions of methylcellulose or derivatives. But all formulations that
are
safe in the dose range you want to cover can be used.
I hope this helps.
Frederic
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